Ibuprofen
- Product NDC
- 53345-039
- 11-digit product format
- 533450039
- Labeler code
- 53345
- Product ID
- 53345-039_8748389d-27ff-47b5-bbe9-03592e2d7d45
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Ibuprofen
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
- Application
- ANDA206568
- Marketing category
- ANDA
- Marketing start
- 2017-07-13
- Substance
- IBUPROFEN
- Active strength
- 200 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ibuprofen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WK2XYI10QM |
| Rxcui | 310964 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53345-039-01 | Ibuprofen | 10000 in 1 BAG | CAPSULE, LIQUID FILLED | 10000 | | 3 |
| 53345-039-01 | Ibuprofen | 1 in 1 BOX | CAPSULE, LIQUID FILLED | 1 | | 3 |
| 53345-039-02 | Ibuprofen | 24 in 1 BOX | CAPSULE, LIQUID FILLED | 24 | | 2 |
| 53345-039-02 | Ibuprofen | 40 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 40 | | 2 |
| 53345-039-03 | Ibuprofen | 100 in 1 BOX | CAPSULE, LIQUID FILLED | 100 | | 2 |
| 53345-039-03 | Ibuprofen | 80 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 80 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53345-039 | IBUPROFEN CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] | 3 | Current NDC, Legacy NDC, 2 package rows | 20191123_daf579dc-91d1-4950-b637-c1a34f5542c5.zip |
| 53345-039 | IBUPROFEN CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] | 2 | Current NDC, Legacy NDC, 4 package rows | 20191123_f42506f7-896c-47a9-a4b1-ed72434d7aa0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53345-039-01 | 53345003901 | 1 BAG in 1 BOX (53345-039-01) / 10000 CAPSULE, LIQUID FILLED in 1 BAG | 1 bag | 2017-03-23 | 0000-00-00 | No | No | Current |
| 53345-039-02 | 53345003902 | 24 BOTTLE in 1 BOX (53345-039-02) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE | 24 bottle | 2017-07-13 | 0000-00-00 | No | No | Current |
| 53345-039-03 | 53345003903 | 100 BOTTLE in 1 BOX (53345-039-03) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE | 100 bottle | 2017-07-13 | 0000-00-00 | No | No | Current |